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FDA Inspection
•Sun Breeze Inc•June 21, 2024

Sun Breeze Inc – FDA Inspection, Jun 21, 2024

Record Details

This FDA Inspection record concerns Sun Breeze Inc, with an inspection on June 21, 2024, issued by the Center for Veterinary Medicine, covering veterinary.

Company
Sun Breeze Inc
Inspection Date
June 21, 2024
Product Type
Veterinary
Office
Center for Veterinary Medicine
Person
  • Stephanie A. Jameson (Issuing Officer)
View Company Profile

ID · aa67304e-9cdd-40f7-9718-6e5bf54a7ff1

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1242225
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices

FDA Citations

10
  1. 21 CFR 111.110(b)Quality control operations - tests, examinations
  2. 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
  3. 21 CFR 111.260(j)(1)Batch record - date, each step
  4. 21 CFR 111.503Written procedures - returned dietary supplement
  5. 21 CFR 111.560(a)(2)Product complaint - quality control investigate
  6. 21 CFR 111.70(d)Specifications - labels, packaging
  7. 21 CFR 111.70(e)Specifications - contamination limits
  8. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  9. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  10. 21 CFR 111.83(a)Reserve sample - collect, hold

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